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  • Title: Phase II trial of second-line bendamustine chemotherapy in relapsed small cell lung cancer patients.
    Author: Schmittel A, Knödler M, Hortig P, Schulze K, Thiel E, Keilholz U.
    Journal: Lung Cancer; 2007 Jan; 55(1):109-13. PubMed ID: 17097191.
    Abstract:
    PURPOSE: The efficacy and toxicity of bendamustine chemotherapy in relapsed small cell lung cancer (SCLC) was determined in this phase II trial. PATIENTS AND METHODS: Patients with cytologically or histologically proven SCLC, who had a sensitive relapse, which was defined as a relapse>or=2 months after completion of primary therapy, were eligible for this study. After informed consent patients received 120 mg/m2 of bendamustine on Days 1 and 2 every 3 weeks. A maximum of six cycles was administered. Primary endpoint was response rate, secondary endpoints included toxicity, progression free survival and overall survival (OS). RESULTS: Twenty-one patients with a median age of 59 years (range 47-76) were accrued to this trial. Six (29%) of 21 patients achieved a confirmed partial remission, 6 (29%) had stable disease and 9 (42%) patients progressed according to RECIST criteria. Median progression free survival was 4 months (95% CI 0-8, 3), median overall survival was 7 months (95% CI 5, 8-8, 2). One- and 2-year survival was 16% and 8%, respectively. Grade III/IV neutropenia occurred in 3 (15%) of 21 patients, 1 patient had a lethal Gram-negative sepsis in neutropenia. Two additional patients had pneumonia in the absence of neutropenia. Two patients (10%) had a grade III anemia, no grade III or IV thrombocytopenia was observed. CONCLUSION: This trial demonstrates efficacy of bendamustine in relapsed SCLC and a favourable toxicity profile. Therefore, single-agent bendamustine is a treatment option for patients with SCLC, who have responded to initial platinum containing chemotherapy and should further be investigated in randomized trials.
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